Amoxicillin/clavulanic acid Ardineclav 500/125 mg powder for oral suspension in sachets EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Amoxicillin/Clavulanic acid ArdineClav 500 mg/125 mg powder for oral suspension in sachets EFG

Read the entire leaflet carefully before you start taking this medicine.

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you (or your child) and should not be given to other people, even if they have the same symptoms, as it may harm them.
• If you consider any of the side effects you experience to be severe, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Leaflet contents:

1. What Amoxicillin/Clavulanic acid ArdineClav is and what it is used for
2. Before taking Amoxicillin/Clavulanic acid ArdineClav
3. How to take Amoxicillin/Clavulanic acid ArdineClav
4. Possible side effects
5. How to store Amoxicillin/Clavulanic acid ArdineClav
6. Further information

1. What Amoxicillin/Clavulanic Acid ArdineClav is and what it is used for

Amoxicillin/Clavulanic Acid ArdineClav is an antibiotic that kills bacteria causing infections. It contains two different active substances called amoxicillin and clavulanic acid. Amoxicillin belongs to a group of medicines known as "penicillins," which may sometimes lose their effectiveness (become inactivated). The other component (clavulanic acid) prevents this from happening.

Amoxicillin/Clavulanic Acid ArdineClav is used in adults and children to treat the following infections:

• Middle ear and sinus infections
• Respiratory tract infections
• Urinary tract infections
• Skin and soft tissue infections, including dental infections
• Bone and joint infections

2. Before taking Amoxicillin/Clavulanic Acid ArdineClav

Do not take Amoxicillin/Clavulanic Acid ArdineClav:

• if you are allergic (hypersensitive) to amoxicillin, clavulanic acid, penicillins, or any of the other ingredients of Amoxicillin/Clavulanic Acid ArdineClav (see section 6)

• if you have ever had a severe allergic reaction (hypersensitivity) to any other antibiotic. This could include skin rash or swelling of the face or neck

• if you have ever had liver problems or jaundice (yellowing of the skin) while taking an antibiotic.

• Do not take Amoxicillin/Clavulanic Acid ArdineClav if any of the above apply to you. Before starting treatment with Amoxicillin/Clavulanic Acid ArdineClav, if you are unsure, consult your doctor or pharmacist.

Take special care with Amoxicillin/Clavulanic Acid ArdineClav

Inform your doctor or pharmacist before taking this medicine if:

• you have infectious mononucleosis
• you are receiving treatment for liver or kidney problems
• you do not urinate regularly.

If you are unsure whether any of the above conditions apply to you, inform your doctor or pharmacist before taking Amoxicillin/Clavulanic Acid ArdineClav.

In some cases, your doctor may investigate the type of bacteria causing your infection. Depending on the results, they may prescribe a different formulation of Amoxicillin/Clavulanic Acid or another medicine.

Symptoms to watch for

Amoxicillin/Clavulanic Acid ArdineClav may worsen certain existing conditions or cause serious adverse effects. These include allergic reactions, seizures, and inflammation of the large intestine. You should be aware of certain symptoms while taking Amoxicillin/Clavulanic Acid ArdineClav to reduce the risk of complications. See "Symptoms to watch for" in section 4.

Blood and urine tests

If you are undergoing blood tests (such as studies of red blood cell status or liver function tests) or urine tests (to monitor glucose levels), inform your doctor or nurse that you are taking Amoxicillin/Clavulanic Acid ArdineClav. This is because Amoxicillin/Clavulanic Acid ArdineClav can alter the results of these types of tests.

Use of other medicines

Inform your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription and herbal medicines.

If you are taking allopurinol (used for gout) together with Amoxicillin/Clavulanic Acid ArdineClav, you may be more likely to develop a skin allergic reaction.

If you are taking probenecid (used to treat gout), your doctor may adjust your dose of Amoxicillin/Clavulanic Acid ArdineClav. Concomitant use of probenecid may reduce the excretion of amoxicillin and is not recommended.

If anticoagulants (such as warfarin) are taken with Amoxicillin/Clavulanic Acid ArdineClav, additional blood tests will be required.

Amoxicillin/Clavulanic Acid ArdineClav may affect the action of methotrexate (a medicine used to treat cancer, severe psoriasis, or rheumatic diseases). Penicillins may reduce the excretion of methotrexate and cause a potential increase in adverse effects.

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, or are breastfeeding, speak with your doctor or pharmacist.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

Amoxicillin/Clavulanic Acid ArdineClav may cause adverse effects, and the symptoms may mean you should not drive.

Do not drive or operate machinery unless you feel well.

Important information about some of the ingredients of Amoxicillin/Clavulanic Acid ArdineClav 500 mg/125 mg powder for oral suspension in sachets

This medicine contains sucrose and glucose. If your doctor has informed you that you have an intolerance to certain sugars, consult with them before taking this medicine.

Patients with diabetes mellitus should be aware that this medicine contains 3.5 g of sucrose per sachet.

3. How to take Amoxicillin/Clavulanic Acid ArdineClav

Follow exactly the instructions for the administration of Amoxicillin/Clavulanic Acid ArdineClav as prescribed by your doctor. Consult your doctor or pharmacist if you have any doubts.

Adults and children weighing 40 kg or more

The usual dose is:

• 1 sachet three times a day

Children weighing less than 40 kg

Amoxicillin/Clavulanic Acid ArdineClav 500 mg/125 mg sachets are not recommended.

Patients with kidney or liver problems

• If you have kidney problems, your dose may need to be adjusted. Your doctor may choose a different formulation or another medicine.
• If you have liver problems, you will have blood tests more frequently to monitor liver function.

How to take Amoxicillin/Clavulanic Acid ArdineClav

• Just before taking Amoxicillin/Clavulanic Acid ArdineClav, open the sachet and mix the contents into half a glass of water or juice. Stir with a spoon to ensure complete homogenization.
• Take it at the beginning of meals or shortly before eating.
• Space your doses evenly throughout the day, at least 4 hours apart. Do not take 2 doses within 1 hour.
• Do not take Amoxicillin/Clavulanic Acid ArdineClav for longer than 2 weeks. If you still feel unwell, consult your doctor.

If you take more Amoxicillin/Clavulanic Acid ArdineClav than you should

If you take too much Amoxicillin/Clavulanic Acid ArdineClav, symptoms such as stomach discomfort (nausea, vomiting, or diarrhea) or seizures may occur. Contact your doctor as soon as possible. Take the packaging with you to show the doctor.

You may also call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Amoxicillin/Clavulanic Acid ArdineClav

If you forget to take a dose, take it as soon as you remember. Do not take the next dose too soon; wait at least 4 hours before taking the following dose.

If you stop taking Amoxicillin/Clavulanic Acid ArdineClav

Continue taking Amoxicillin/Clavulanic Acid ArdineClav for the full duration of the treatment, even if you start feeling better. You need to complete the full course to cure the infection. If you do not, surviving bacteria may cause the infection to return.

If you have any further questions about the use of this product, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Amoxicillin/Clavulanic acid ArdineClav may cause adverse effects, although not everyone experiences them. The adverse effects listed below may occur when taking this medicine.

Symptoms you should be aware of

Allergic reactions:

• skin rash

• inflammation of blood vessels (vasculitis), which may appear as red or purple spots on the skin, but may also affect other parts of the body

• fever, joint pain, swollen glands in the neck, armpits, or groin

• swelling, sometimes of the face or mouth (angioedema), causing difficulty breathing

• collapse

• Contact your doctor immediately if you experience any of these symptoms. Stop taking Amoxicillin/Clavulanic acid ArdineClav.

Inflammation of the large intestine

Inflammation of the large intestine, causing watery diarrhoea, usually with blood and mucus, stomach pain and/or fever.

• Contact your doctor as soon as possible for advice if you have these symptoms.

Very common adverse effects

May affect more than 1 in 10 patients

• diarrhoea (in adults)

Common adverse effects

May affect up to 1 in 10 patients

• mouth ulcers (candida – fungal infection in the vagina, mouth or mucous membranes)

• nausea, especially when taking high doses

• if this occurs, take Amoxicillin/Clavulanic acid ArdineClav before meals

• vomiting

• diarrhoea (in children)

Uncommon adverse effects

May affect 1 in 100 patients

• skin rash, itching
• increased itchy rash (urticarial wheals)
• indigestion
• dizziness
• headache

Uncommon adverse effects that may appear in blood tests:

• Increase in certain substances (enzymes) produced by the liver.

Rare adverse effects

May affect up to 1 in 1,000 patients

• skin rash that may form blisters resembling small targets (a dark central spot surrounded by a paler area, with a dark ring around the edge – erythema multiforme)

• if you experience any of these symptoms, consult your doctor urgently

Rare adverse effects that may appear in blood tests:

• low count of cells involved in blood clotting
• low white blood cell count

Other adverse effects

Other adverse effects that have occurred in a very small number of patients, with unknown frequency:

• Allergic reactions (see above)

• Inflammation of the large intestine (see above)

• Inflammation of the protective membrane surrounding the brain (aseptic meningitis)

• Severe skin reactions:

  • widespread rash with blisters and peeling of the skin, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome), and in its most severe form, causing widespread skin peeling (more than 30% of body surface – toxic epidermal necrolysis)
  • widespread rash with small pus-filled blisters (exfoliative bullous dermatitis)
  • red rash with bumps under the skin and blisters (exanthematous pustulosis)
  • flu-like symptoms with skin rash, fever, swollen glands and abnormal blood test results (such as increased white blood cells (eosinophilia) and elevated liver enzymes) (drug reaction with eosinophilia and systemic symptoms (DRESS))

• Chest pain in the context of allergic reactions, which may be a symptom of an allergic-triggered heart attack (Kounis syndrome)

• Drug-induced enterocolitis syndrome (DIES): DIES has mainly been reported in children receiving amoxicillin. It is a type of allergic reaction with the main symptom of repeated vomiting (1–4 hours after taking the medicine). Other symptoms may include abdominal pain, lethargy, diarrhoea and low blood pressure

• Crystals in the urine causing acute kidney injury

• Blistering rash arranged in circles with a central crust or resembling a string of pearls (linear IgA disease)

• Inflammation of the membranes covering the brain and spinal cord (aseptic meningitis)

• Acute inflammation of the pancreas (acute pancreatitis)

If you have severe and persistent pain in the stomach area, this could be a sign of acute pancreatitis.

• Contact a doctor immediately if you have any of these symptoms.

• inflammation of the liver (hepatitis)

• jaundice, caused by increased bilirubin in the blood (a substance produced by the liver), which may cause the skin and whites of the eyes to turn yellowish

• inflammation of the kidney tubules

• delayed blood clotting

• hyperactivity

• seizures (in patients taking high doses of Amoxicillin/Clavulanic acid or who have kidney problems)

• black, hairy-looking tongue

• stained teeth (in children), which usually disappears with brushing

Adverse effects that may appear in blood or urine tests:

• marked decrease in white blood cell count
• low red blood cell count (haemolytic anaemia)
• crystals in the urine

If you experience adverse effects

• If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: http://www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Amoxicillin/Clavulanic Acid ArdineClav

Do not store above 25°C.

Keep in the original packaging to protect from light and moisture.

Keep out of the reach and sight of children.

Do not use Amoxicillin/Clavulanic Acid ArdineClav after the expiry date stated on the packaging. The expiry date refers to the last day of the month indicated.

Do not use Amoxicillin/Clavulanic Acid ArdineClav if the sachets are torn or damaged.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.

6. Additional Information

Composition of Amoxicillin/Clavulanic Acid ArdineClav 500 mg/125 mg powder for oral suspension in sachets

The active substances are Amoxicillin and Clavulanic Acid. Each sachet contains:

Amoxicillin (as amoxicillin trihydrate) 500 mg
Clavulanic Acid (as potassium clavulanate) 125 mg

The other components (excipients) are: Silicon dioxide, anhydrous trisodium citrate, sucrose, raspberry flavouring (containing glucose in maltodextrin derived from maize and glucose), and fruit flavouring (containing glucose).

Appearance of the medicinal product and contents of the container

Yellowish-white powder with a pleasant taste.

Pack sizes: 30 and 500 sachets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

LABORATORIO REIG JOFRÉ, S.A.
Gran Capitán, 10, 08970 Sant Joan Despí (Barcelona)

Manufacturer:

Laboratorio REIG JOFRE, S.A
C/Jarama 111. Pol Industrial
45007 Toledo

This leaflet was last reviewed in January 2023.

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es

Reconstitution instructions

Pour the contents of the sachet into 10–20 ml of water, shake until a suspension is obtained, and take immediately.